PC Electrometer Reference Class Dual-Channel Elect 10140000Z

GUDID B01610140000Z0

Radiation therapy QA device.

SUN NUCLEAR CORP.

Radiation electrometer
Primary Device IDB01610140000Z0
NIH Device Record Keyad59f4c2-953b-4470-a7e1-ff38489579a8
Commercial Distribution Discontinuation2019-03-19
Commercial Distribution StatusNot in Commercial Distribution
Brand NamePC Electrometer Reference Class Dual-Channel Elect
Version Model Number10140000Z
Catalog Number10140000Z
Company DUNS122240021
Company NameSUN NUCLEAR CORP.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store the instrument in an indoor, protected environment where it will not be irradiated by the direct beam and where scattered radiation will be kept at a minimum.
Special Storage Condition, SpecifyBetween 0 and 0 *Before storage, install caps on both detector inputs. The input connector interior has high impedance; the caps protect the inputs from contamination which could cause increased leakage current.
Handling Environment Atmospheric PressureBetween 18.7 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric PressureBetween 57.2 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the instrument in an indoor, protected environment where it will not be irradiated by the direct beam and where scattered radiation will be kept at a minimum.
Special Storage Condition, SpecifyBetween 0 and 0 *Before storage, install caps on both detector inputs. The input connector interior has high impedance; the caps protect the inputs from contamination which could cause increased leakage current.
Handling Environment Atmospheric PressureBetween 18.7 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Storage Environment Atmospheric PressureBetween 57.2 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB01610140000Z0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IYEAccelerator, Linear, Medical

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-03-19
Device Publish Date2017-01-14

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